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510(k) Data Aggregation
K Number
K192557Device Name
Youjia Unscented Tampon with Plastic Applicators
Manufacturer
Date Cleared
2020-02-13
(149 days)
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Youjia Hygiene Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Youjia unscented tampon with plastic applicators are inserted into the vagina and used to absorb menstrual and other vaginal discharge.
Device Description
Youjia unscented tampon with plastic applicators are composed of an absorbent pledget (tampon), a withdrawal cord and an applicator. The pledgets have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. These tampons are provided in three absorbencies: regular (6-9g), super, (9-12g), and super plus (12-15g). Each tampon is individually wrapped and packaged. The Youjia unscented tampon with plastic applicators are provided non-sterile and for single use only.
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K Number
K190218Device Name
Unscented Menstrual Tampon
Manufacturer
Date Cleared
2019-05-09
(94 days)
Product Code
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Youjia Hygiene Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.
Device Description
The BiuBiu tampon is composed of an absorbent pledget (tampon), a withdrawal cord, and an applicator. The pledgets (cleared under K090819) have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. The barrel of the applicator has a no-slip grip design to help hold the tampon tightly. Each tampon is individually wrapped and packaged. There are three versions of the BiuBiu tampon with different absorbencies: regular, super and super plus. Each version has a different color applicator. The BiuBiu tampon is provided non-sterile and for single use only.
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